[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5672]
[[Page Unknown]]
[Federal Register: March 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 92E-0506]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PRO OSTEONTM Implant 500 Coralline Hydroxyapatite Bone
Void Filler
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for PRO OSTEONTM Implant 500 Coralline
Hydroxyapatite Bone Void Filler and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Commissioner of
Patents and Trademarks, Department of Commerce, for the extension of a
patent which claims that medical device.
ADDRESSES: Written comments and petitions should be directed to the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John S. Ensign, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-1382.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Commissioner of Patents and Trademarks may award
(half the testing phase must be subtracted as well as any time that may
have occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing the medical device PRO
OSTEONTM Implant 500 Coralline Hydroxyapatite Bone Void Filler.
The PRO OSTEONTM Implant 500 Coralline Hydroxyapatite Bone Void
Filler is indicated for the repair of acute metaphyseal fracture
defects and is to be used in conjunction with rigid internal fixation
as dictated by the clinical use requirements in skeletally mature
individuals when there is no autogenous bone donor site available.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for the PRO OSTEONTM Implant
500 Coralline Hydroxyapatite Bone Void Filler (U.S. Patent No.
3,929,971) from Research Corp. Technologies, and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. FDA, in a letter
dated December 31, 1992, advised the Patent and Trademark Office that
this medical device had undergone a regulatory review period and that
the approval of the PRO OSTEONTM Implant 500 Coralline
Hydroxyapatite Bone Void Filler represented the first commercial
marketing of the product. Shortly thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
FDA has determined that the applicable regulatory review period for
PRO OSTEONTM Implant 500 Coralline Hydroxyapatite Bone Void Filler
is 3,774 days. Of this time, 2,049 days occurred during the testing
phase of the regulatory review period, while 1,725 days occurred during
the approval phase. These periods of time were derived from the
following dates:
1. The date a clinical investigation on humans involving this
device was begun: July 2, 1982. FDA has verified the applicant's claim
that the investigational device exemption required under section 520(g)
of the Federal Food, Drug, and Cosmetic Act became effective on July 2,
1982.
2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act: February 9, 1988. The applicant claims February 8, 1986, as the
date the premarket approval application (PMA) for the PRO OSTEONTM
Implant 500 Coralline Hydroxyapatite Bone Void Filler (PMA P860005) was
filed. However, FDA records indicate that PMA P860005 was initially
submitted on February 9, 1988.
3. The date the application was approved: October 29, 1992. FDA has
verified the applicant's claim that PMA P860005 was approved on October
29, 1992.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 730 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before May 10, 1994, submit to the Dockets
Management Branch (address above) written comments and ask for a
redetermination. Furthermore, any interested person may petition FDA,
on or before September 7, 1994, for a determination regarding whether
the applicant for extension acted with due diligence during the
regulatory review period. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
Comments and petitions should be submitted to the Dockets
Management Branch (address above) in three copies (except that
individuals may submit single copies) and identified with the docket
number found in brackets in the heading of this document. Comments and
petitions may be seen in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: December 28, 1993.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-5672 Filed 3-10-94; 8:45 am]
BILLING CODE 4160-01-F